Evaluating the Effects of Psycho-oncological Education on Distress and Quality of Life in Solid Tumor Cancer Patients

Not Applicable

Completed

• Conditions: Quality of Life
• Interventions: Other: Education

• Registration Number: NCT02370836
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

This study evaluates that effects of psycho-oncological education on distress and quality of life in solid tumor cancer patients who have completed chemotherapy with curative intent. Half of the participants will received a psycho-oncological educational intervention while the other half will receive usual care.

Detailed Description

Solid tumor cancer patients who have completed chemotherapy with curative intent experience psychological distress. As a result these patients experience poorer quality of life (QOL), emotional vulnerability and unnecessary emotional suffering.

Purpose: To determine whether the implementation of a nurse driven psycho-oncological educational session will decrease psychological distress levels and improve QOL among solid tumor cancer patients who have received and completed chemotherapy with curative intent.

Methods: A randomized clinical trial (RCT) consisting of 28 eligible patients at Sibley Memorial Hospital will be used to compare the effect of psycho-oncological education to treatment as usual in reducing psychological distress and improving quality of life. The intervention group will receive one 60 minute session of psycho-oncological education. The comparison group will receive usual care only which includes a general information session offered prior to any treatment which addresses broad side-effects of treatment, an overview of the treatment process and identification of additional resources. Participants will be assessed for psychological distress and QOL levels at baseline and two weeks after the intervention.

Study Timeline

• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-25
• Study Start: 2015-05
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• non-race specific
• solid tumor cancer patient
• completed chemotherapy with curative intent

Exclusion Criteria

• diagnosis of cancer prior to cancer they are being treated for
• distress score of 8 or greater
• diagnosed with a psychiatric disorder
• diagnosed with lymphoma or leukemia
• in need of immediate crisis support

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psycho-oncological education	Education	One 60 minute psycho-oncological education session on late effects, fatigue and stress management.

Primary Outcome Measures

Name	Time	Method
Distress Thermometer (self-reported distress levels by 11 point scale) Change is being assessed	at baseline & two weeks after intervention	Self reported distress levels at baseline and two weeks after the intervention. Scale is 11-points from 0(no distress) to 10 (extreme distress)

Secondary Outcome Measures

Name	Time	Method
World Health Organization Quality of Life BREF (WHOQOL-BREF) Change is being assessed.	at baseline & two weeks after intervention	Self- report, 24 question scale representing 6 domains related to quality of life. Quality of life to be measured at baseline and two weeks post intervention.